(198 days)
Candela PLDL-1, Laserscope 532nm KTP, Redfield IR Coagulator
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No
The summary describes a photothermal treatment device and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML development.
Yes
The device is intended for the "treatment" of benign pigmented lesions and tattoos, which is a therapeutic purpose.
No
The device is described as a "system intended for the treatment of benign pigmented lesions and tattoos" and an "electro optic medical device designed for effective photothermal treatment." Its purpose is therapeutic, not diagnostic.
No
The device description explicitly states it is an "electro optic medical device," indicating it includes hardware components beyond just software.
Based on the provided information, the PhotoDerm PL is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of benign pigmented lesions and tattoos. IVD devices are used for the diagnosis or monitoring of diseases or conditions by examining samples taken from the body (like blood, urine, tissue).
- Device Description: The description states it's an "electro optic medical device designed for effective photothermal treatment". This aligns with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
The PhotoDerm PL is a therapeutic device that uses light energy to treat conditions directly on the patient's body.
N/A
Intended Use / Indications for Use
The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos.
Product codes
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Device Description
PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
A theoretical study was conducted to establish the temperature distribution resulting from a treatment of pigmented lesions and tattoos by the PhotoDerm PL. The temperatures reached by a wide range of lesions, typical to benign pigmented lesions exposed to the light energy of the PhotoDerm PL, was evaluated.
In addition, ESC Medical Systems has also conducted a multi-center clinical study in which benign pigmented lesions were treated by the PhotoDerm PL. This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm PL were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices.
Key Metrics
clearance rates, rate of occurrence of adverse effects
Predicate Device(s)
Candela PLDL-1, Laserscope 532nm KTP, Redfield IR Coagulator
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
SEP 1 1 1996
K 960772
1. 510(K) SUMMARY- SUMMARY OF SAFETY AND EFFECTIVENESS
ESC Medical Systems, Ltd Submitter's name: Submitter's address: Matam- Science and Industry Park Haifa, 31905 Israel 011-972-4-574-123 Telephone: Fax: 001-972-4-574-131 PhotoDerm® PL Name of device: Predicate devices: Candela PLDL-1 Laserscope 532nm KTP Redfield IR Coagulator
Description of device: PhotoDerm PL is an electro optic medical device designed for effective photothermal treatment of benign pigmented lesions and tattoos non-invasively.
Summary:
Pursuant to section 513(I) of the Safe Medical Devices Act of 1990, ESC Medical Systems has elected to include in this premarket notification a Summary of Safety and Effectiveness upon which we believe a substantial equivalence determination for the PhotoDerm PL can be based.
It is our understanding that there are presently no FDA regulations describing the form and content of such Summaries. With this in mind, ESC Medical Systems has tried to anticipate what information may be of particular interest to the agency regarding safety and effectiveness of the PhotoDerm PL.
Intended use:
The PhotoDerm PL is a system intended for the treatment of benign pigmented lesions and tattoos. The Candela PLDL-1, Laserscope 532 KTP, and the Redfield IR Coagulator have been classified as Class II devices and were reviewed by the General and Plastic Surgery Devices Panel. ESC Medical Systems claims that the PhotoDerm PL is substantially equivalent to these devices.
1
Comparing technical characteristics:
Both a technical comparison and clinical trials were performed by ESC Medical Systems to establish nis equivalence:
ESC has performed a detailed comparison of the technical specifications of these predicate devices and the PhotoDerm PL. The results have documented that the system specifications of the PhotoDerm PL are well within the range of the technical specifications of the predicate devices.
A theoretical study was conducted to establish the temperature distribution resulting from a treatment of pigmented lesions and tattoos by the PhotoDerm PL. The temperatures reached by a wide range of lesions, typical to benign pigmented lesions exposed to the light energy of the PhotoDerm PL, was evaluated. It is the view of ESC Medical Systems that this analysis demonstrates that the PhotoDerm PL is an effective treatment modality of benign pigmented lesions and tattoos, and is safe in minimizing the adverse effects in the surrounding tissues.
Performance:
In addition, ESC Medical Systems has also conducted a multi-center clinical study in which benign pigmented lesions were treated by the PhotoDerm PL. This study was analyzed and the clearance rates and rate of occurrence of adverse effects of the PhotoDerm PL were established. This data was compared to published data on the clearance rate and adverse effects of predicate devices. It is ESC's opinion that this comparison demonstrates that the PhotoDerm PL is as safe and as effective as predicate devices in the treatment of benign pigmented lesions.
No performance standards applicable to the PhotoDerm PL have been adopted under Section 514 of the Act. However,
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PhotoDerm PL is an electro medical device and conforms with the voluntary international standard IEC601.1-1. Medical Electrical Equipment, Part 1: General Requirements for Safety.
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Although PhotoDerm PL is not a laser device, substantial equivalence for laser devices is being claimed. As such ESC has made efforts to comply, where applicable, with 21 CFR 1040.1 FDA laser performance standard.
In summary we believe that the analysis, the clinical data and the standards which the PhotoDerm PL meets make it substantially equivalent to predicate devices.